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510(k) K972302

POCKET COUNT OR SAFETCOUNT by Sage Products, Inc. — Product Code LWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1997
Date Received
June 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
Review Panel
SU
Submission Type

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  • K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER (October 29, 1997)
  • K972279 — SHARPS SHUTTLE (August 29, 1997)
  • K970135 — NITRILE GLOVES (August 25, 1997)
  • K964168 — PROCEDURE SPECIFIC KITS (March 3, 1997)
  • K963986 — STP SYSTEM PVA WITH ZINC (November 8, 1996)
  • K964026 — STP SYSTEM - SAF (November 7, 1996)
  • K964027 — STP SYSTEM-PVA WITH MERCURY (November 1, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (July 22, 1996)

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  • K061316 — MEDLINE SURGICAL SPONGE SCANNER (November 2, 2006)
  • K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM (March 14, 2006)
  • K982260 — MARKWELL GAUZE SPONGE (August 12, 1998)